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Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

NCT ID: NCT00279630

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2014-12-31

Brief Summary

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Posterior tibial tendon dysfunction (PTTD) is the most common cause of painful and debilitating acquired flatfoot deformity in adults. The dysfunction is often progressive and may result in attenuation of the PTT and eventually collapse of the plantar arch or even rupture of the tendon. Current therapeutic management of PTTD is multipronged and includes management with foot orthoses, stretching, and strengthening exercises. Evidence drawn from research related to the management of painful chronic Achilles tendinosis suggests that eccentric strengthening of the posterior tibialis may lead to superior results compared to concentric. The purpose of this research is to determine the effectiveness of treatment interventions used in the management of PTTD.

Detailed Description

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All study participants receive a pair of custom made orthoses and perform daily calf-stretches. In addition to the orthoses two groups will perform tibialis posterior specific exercises; one as concentric and the second as eccentric activation. Intervention will last 12 weeks.

Conditions

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Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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type of exericse

type of exercise

Group Type EXPERIMENTAL

Orthoses and Exercise

Intervention Type PROCEDURE

orthrose and exercise - daily

Interventions

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Orthoses and Exercise

orthrose and exercise - daily

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pain (\> 3 months duration)
* Pain localized to the medial ankle and foot
* Swelling at the medial ankle
* Able to perform a single controlled heel lowering

Exclusion Criteria

* Bilateral posterior tibial tendon dysfunction
* Fixed foot deformities
* Previous foot surgery
* Presence of any other concurrent foot pathology besides posterior tibial tendon dysfunction
* Ability to walk only with assistive device
* Neurological disorders
* Cognitive dysfunction
* Uncontrolled cardiovascular disease
* Evidence of cord compression
* Uncontrolled hypertension
* Infection
* Severe respiratory disease
* Pregnancy
* Current or recent history of low back pain
* Known rheumatic joint disease
* Peripheral vascular disease with sensory loss of the foot.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Kornelia Kulig

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kornelia Kulig, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Department of Biokinesiology and Physical Therapy

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Kulig K, Pomrantz AB, Burnfield JM, Reischl SF, Mais-Requejo S, Thordarson DB, Smith RW. Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630]. BMC Musculoskelet Disord. 2006 Jun 6;7:49. doi: 10.1186/1471-2474-7-49.

Reference Type DERIVED
PMID: 16756656 (View on PubMed)

Other Identifiers

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022051

Identifier Type: -

Identifier Source: org_study_id